tc176/iaf iso 9001:2000 - · the credibility of iso 9001:2000 certification. auditing practices...

TC176/IAFISO 9001:2000

Auditing Practices Group

The ISO 9000 Advisory Group identified auditor competence as a critical issue when ensuring the credibility of ISO 9001:2000 certification.

Auditing Practices Group established in February 2003.

Participants

Experts nominated by:-• IAF (CRBs, ABs, Industry)• ISO TC/176(WG Int, SC1, SC2, SC3)• ISO CASCO

Aims of the Group1. Development of examples of good auditing

practices related to requirements of ISO9001: 2000 and guidelines of ISO19011: 2002

2. Development of a website where papers and examples of auditing practice against the requirements of ISO 9001:2000 are posted and available to the public without charge.

3. The information provided by the Group does not constitute IAF or ISO endorsed benchmarks or interpretations of the preferred way conformance to ISO 9001:2000 is audited.APG-Introduction.doc

Topics• The need for a 2-stage approach to auditing • Measuring QMS effectiveness and improvements • Identification of processes • Understanding the process approach • Determination of the “where appropriate” processes • Auditing the “where appropriate” requirements • Demonstrating conformity to the standard • Linking an audit of a particular task, activity or

process to the overall system

Topics• Auditing a QMS which has minimum documentation • How to audit top management processes • The role and value of the audit checklist• Scope of ISO 9001:2000, scope of quality

management system and defining scope of certification

• How to add value during the audit process• Auditing competence of personnel and the

effectiveness of actions taken• Auditing statutory and regulatory requirements

Topics• Auditing quality policy and quality objectives• Auditing the control of monitoring and measuring

devices• Effective use of ISO 19011:2002• Auditing customer feedback processes• Documenting a nonconformity• Reviewing and closing a nonconformity• Auditing preventive action• Auditing continual improvement

Topics

• Auditing service organizations

• Auditing Internal Communication

• Third party auditor impartiality and conflict of interest

• Auditing the effectiveness of the internal audit

• Auditing Electronic-Based Management Systems (EBMS)

Topics

• Auditing the Design and Development Process

• Auditor Code of Conduct and Ethics

• Auditing the Management of Resources

Accreditation Auditing Practices Group (AAPG) Topics

• The Witnessing of CRB Audits by an Accreditation Body

• “Process approach" based accreditation audits

• Auditing the competence of quality managementsystem certification/registration body auditors and audit teams

The need for a 2 stage approach to auditing

• Auditing to ISO 9001:2000 requires a good understanding of the business and QMS

• The primary purpose of the 1st stage audit

• Activities performed during the 1st stage audit

APG-2stage.doc

Measuring QMS effectiveness and improvements

(Open presentation)

Microsoft owerPoint Presentatio

Identification of Processes• Can the auditee distinguish between processes and

activities?

• Be able to adapt to the auditee’s situation

• Determine if there is a problem with difference in terminology

• Determine if there is a real lack of implementation of the process approach

APG-IdentifyProcesses.doc

Understanding the process approach (1)

The Auditor should realise several steps are needed• Determine the processes and responsibilities needed

to attain objectives• Determine and provide adequate resources and

information• Establish and apply methods to monitor and analyse

processes• Establish and apply a process for continual

improvement


The Auditor also needs to:-• Be aware that application of the process approach

will be different from organization to organization• Understand the process approach to a level beyond

the terminology of the standard• Consider small & medium enterprises who may not

need many processes• Ensure that misunderstandings are identified and

resolved during the 1st stage audit


The Auditee needs to consider:-• Establishment of process objectives• Process planning• Availability of suitable records

Redefinition of processes during the 1st stage audit can identify activities incorrectly described as processes

APG-UnderstandProcessApproach.doc

Determination of the “where appropriate” processes

• Terminology• Definition of process• Exclusions

APG-DetermineWhereAppropriate.doc

Auditing “where appropriate”requirements (1)

• Determine the application of ISO 9001:2000• Ensure “where appropriate” requirements are

appropriate• Does the requirement add value?• Does it increase the risk of not meeting customer

requirements?

Auditing “where appropriate”requirements (2)

Need for experience to make a judgement on a technical issue

• Sector knowledge• Competence • Auditing skills• Knowledge of the processes• Objective evidence

APG-AuditWhereAppropriate.doc

Demonstrating conformity to the standard

• Auditing processes versus auditing to the standard's clauses

• Audit checklists may not be sufficient• What is adequate sampling?

APG-DemonstrateConformity.doc

Linking an audit of a particular task, activity or process to the

overall system

• Overall direction of the audit• Interaction of processes• Importance of processes• Take samples

APG-AuditofTasktoSystem.doc

Auditing continual improvement

• How much improvement is “enough”? • What sort of information is relevant and where can

we find it? • Improvement of the process or improvement of the

QMS?

APG-AuditContinualImprovement.doc

Auditing a QMS which has minimum documentation

The necessity for any documentation should be evaluated in the light of:• the observed need for consistency• the role that any documentation could play

in avoiding any significant, identified risks.

APG-MinDocumentation.doc

How to audit top management processes

• Identifying top management processes• Conducting the audit• Audit reporting

APG-AuditTopManagement.doc

The role and value of the audit checklist

• Need for checklists• The use of audit checklists• Advantages• Disadvantages• Conclusion

APG-Checklist.doc

Scope of ISO 9001:2000, Scope of Quality Management System (QMS) and Defining

Scope of Certification

• ISO 9001:2000 clause 1 Scope defines the scope of the standard, not to be confused with QMS scope

• The scope of a QMS should be based on the:– nature of products and realization processes – result of risk assessment– commercial considerations – contractual, statutory and regulatory requirements– ISO 9001:2000 clause 1.2 Application

• Scope of registration/certificationAPG-Scope.doc

How to add value during the audit process (1)

• “Value-added” quality management systems• Value-added auditing

Maturity of “Quality culture”

Mat

urity

of Q

MS

Mat

urity

of Q

MS

LowLow HighHigh

““ Non

Non

-- con

form

ing”

conf

orm

ing”

“Con

form

ing”

Zone 1 Zone 2

Zone 3 Zone 4

How to add value during the audit process (2)

Some tips for Value-added auditing• Audit planning• Audit technique• Analysis and decision• Report and follow-up

APG-HowtoAddValue.doc

An organization will need to:• Identify what competencies are required• Identify which personnel already are competent• Decide what additional competencies are required• Decide how these are to be obtained • Train, hire or reassign personnel• review competence of personnel

Auditing 'competence' and 'effectiveness of actions taken'

(1)

Auditing 'competence' and 'effectiveness of actions taken‘

(2)Auditor would seek evidence of:• Identification of competencies required• Assignment of competent personnel• Evaluation of the effectiveness of actions taken• Maintenance of competence

APG-AuditingCompetence.doc

Auditing statutory and regulatory requirements

• An organization must identify and control the statutory and regulatory requirements applicable to its products (including services).

• Evidence should be obtained that these requirements are being satisfied

APG-StatutoryRegulatory.doc

Auditing quality policy and objectives (1)

Auditing quality policy• Interview top management to verify that the

organization’s overall quality objectives have been defined

• Evaluate commitment and involvement• Have management disseminated the policy

throughout the organization?• Determine awareness among personnel at all levels

Auditing quality policy and objectives (2)

Auditing quality objectives• Verify that the organization’s overall quality objectives

have been defined• Do they reflect the quality policy?• Are they coherent, aligned and compatible with the

overall business objectives, including customer expectations?

APG-QualityPolicyandObjectives.doc

Auditing the control of monitoring and measuring

devicesIt is important for the auditor to understand the

differences between:-• “monitoring” and “measurement”, and • “equipment” and “devices”.

The different sub-clauses of the standard refer to all of these in isolation and together so clause 7.6 should be read carefully.

APG-ISO9001Clause7.6.doc

Effective use of ISO19011:2002

The standard contains guidance on:-• The principles of auditing• Managing an audit programme• Audit activities• Competence and evaluation of auditors

APG-EffectiveUseofISO19011.doc

Auditing customer feedback processes

• What are the requirements?

• What should be addressed when auditing customer feedback processes?– Prior to the audit of the customer feedback

process (preparation stage)– During the process assessment

APG-CustomerFeedback.doc

Documenting a nonconformity

• What is a nonconformity?

• Identify and document the audit evidence• Determine the requirement• Write the statement of nonconformity

APG-DocumentNonconformity.doc

Reviewing and closing a nonconformity

Auditors not only write nonconformities but are also responsible for the review of the response to the nonconformity

• Correction• Determination of cause• Corrective action• Objective evidence• Closing nonconformitiesAPG-ReviewNonconformity2.doc

Auditing preventive actionHow the organization:• Determines potential nonconformities &

causes• Evaluates the need for preventive action• Determines action required & how it is

implemented• Records results of actions taken• Reviews preventive actions taken

“Philosophical” discussion - auditor and auditeeAPG-ReviewNonconformity2.doc

Auditing service organizations• Design and development of the service• Validation of processes for production and

service provision• 2 types of Services

- those involving the customer in the realization of the service itself (real time delivery) and

- those in which the output is delivered to the customer after the realization of the process

• Control of nonconforming product

Auditing Internal Communication

• Identification of the people between whom the communication is to occur

• Information to be communicated• Means by which this is to be achieved• Methods selected to monitor its effectiveness• Documentation and records necessary to verify it

has occurred

Third party auditor impartiality and conflict of interest

• CRB commitment to impartiality• Threats to auditor impartiality• Safeguards to auditor impartiality• Assessing the level of impartiality risk• Determining the acceptability of the level of

impartiality risk• Organizational and structural issues

Auditing the effectiveness of the internal audit

Issues to evaluate :• the competencies that are needed for and applied to

the audit • the risk analysis performed by the organization (if

any) in planning internal audits• the degree of management involvement in the

internal audit process • the way the outcome of the internal audit process is

used by the organization to evaluate the effectiveness of its QMS and to identify opportunities for improvements.

Auditing Electronic-Based Management Systems (EBMS)

• Audit Initiation and Planning• Document Review• On-Site Realization Activities• Auditing the Control of Electronic Documents• Auditing the Control of Electronic Records• Organizational Resources• Internal and External Electronic Communication• Multi-Site Management Systems• Auditor Competence

The Witnessing of CRB Audits by an Accreditation Body

• Pre-audit preparations

• During the audit

• Feedback and reporting of results

“Process approach" based accreditation audits

• CRB objectives

• Typical processes of CRBs

• Example of questions to be asked by an AB during a process based audit

Auditing the competence of quality management

system CRB auditors and audit teams

• Evaluation of auditor qualifications and competence• Personal attributes • Generic knowledge and skills• Processes and products• Size of Organizations• Culture and Language• Legal, statutory, and regulatory requirements• Evaluation of competence requirements• Deployment of a team of competent auditors

Copies of the guidance documents referred to in this presentation can be obtained from:

www.iaf.nuwww.iso.org/tc176/ISO9001AuditingPracticesGroup

Comments on the papers or presentations can be sent to the following email address:

[email protected]

Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance

documents should be developed, or if these current ones should be revised.

DisclaimerThese papers have not been subject to an endorsement

process by the International Organization for Standardization (ISO), ISO Technical Committee 176, or the International Accreditation Forum (IAF).

The information contained within them is available for educational and communication purposes. The ISO 9001 Auditing Practices Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.

Thank you!

Auditing Practices Group &

Accreditation Auditing Practices Group